Page Last Updated: 17 July 2024
The following company types must register in EUDAMED:
These organizations are ‘Economic Operators’ and will register themselves in the EUDAMED ‘Actor’ registration module.
There are several terms that are important to know for EUDAMED.
Economic Operators are organizations involved in the supply of medical devices onto the European Market. They are defined in the MDR/IVDR as: (all) Manufacturers, (all) System/Procedure Pack Producers, (EU) Authorized Representatives, (EU) Importers, and (EU) Distributors.
Not all Economic Operators require registration in the EUDAMED Actor module. While distributors are also Economic Operators (and must meet certain obligations under the MDR/IVDR), they are not registered in EUDAMED.
An Actor is any organization that is required to register in EUDAMED. Per the EU Commission’s document:
“An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.”
Actors include the Economic Operators discussed above. However, Actors also include Supervising Entities.
Supervising Entities are those responsible for medical device oversight, including CE Marking certification. Specifically, these are: the European Commission, Competent Authorities, Designating Bodies, and Notified Bodies.
Manufacturer = Economic Operator = Actor |
System/Procedure Pack Producer = Economic Operator = Actor |
EU Authorized Representative = Economic Operator = Actor |
EU Importer = Economic Operator = Actor |
EU Distributor = Economic Operator ≠ Actor |
EUDAMED is currently voluntary; its mandatory use date has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EUDAMED Gradual Rollout (starting 2025)
Until EUDAMED is mandatory, the registration requirements under the old Directives (MDD/AIMDD/IVDD) continue to apply.
For an overview of which devices currently require registration, and where, please read: EU Medical Device & IVD Registration Requirements
NOTE: many Notified Bodies already require that manufacturers complete this registration, even though it is technically voluntary, as do some Competent Authorities.
The process is fairly straight-forward. However, please refer to the EU Commission’s User Guide and video (no sound) for detailed instructions on the process. Download the User Manual titled ‘Economic Operators’ under the ‘Actors’ tab.
*We recommend you complete these (have them ready) before starting the registration application.
Whether you need a quote or just want to discuss the best options for your business, we will help guide you.
Timing depends on your Authorized Representative, if applicable, and the Competent Authority.
The total timeframe, therefore, depends on how long it takes:
Each Competent Authority has a different target based on its own resources and goals. Some Competent Authorities will review Actor requests within 2-3 working days. However, some estimate 2 or more weeks to process Actor requests. Further, some are stricter than others. For example, some may reject an Actor registration for not entering their local “company registration number” or if the street name is abbreviated.
The person who submits the EUDAMED Actor registration request, by default, becomes the account’s Local Actor Administrator (LAA). This is the highest-level access role, and this person is responsible for granting access to other employees.
Note that your company must appoint at least one additional (back-up) LAA in order to submit device registrations. The UDI/Device Registration Module will not activate until your account has at least two LAAs assigned.
Steps for secondary Local Actor Administrators (LAAs):
Steps for the original Local Actor Administrator (LAA):
The original Local Actor Administrator will receive an email notifying them of the above request. To approve it, they will:
The full list of steps, with images, are outlined on page 50 of the EUDAMED Actor User Manual.
Once the Competent Authority approves the Actor registration, they will then issue the Single Registration Number (SRN).
The EUDAMED Single Registration Number (SRN) is the output of completing your Actor registration.
For more information on what an SRN is and how it is used, please read: What is a EUDAMED Single Registration Number?
After you have completed the Actor registration:
For more information on the device registration process, please read: EU Guide: Registering medical devices in EUDAMED
An EU Authorized Representative (AR) will not review Actor registration requests for System/Procedure Pack Producers (S/PPP), even if the S/PPP is not based in the EU. Instead, the non-EU S/PPP should identify the most applicable Competent Authority (CA) to review the request.
As general practice, the S/PPP should select the same CA as where their EU AR is located, even though the EU AR will not review the S/PPP request. The Irish CA, for example, recommends this on their website; and further asks that the S/PPP include the EU AR’s information in the application comments section for faster processing.
Note that System/Procedure Pack Producers are issued an Actor ID, instead of a Single Registration Number. For all practical purposes, the Actor ID and SRN look the same and serve the same purpose.
Most custom-made device manufacturers are exempt from EUDAMED registration requirements. The exceptions are:
Class III custom-made implantable devices require Notified Body certification, covering the quality management system. And the Notified Body must then register it in the Notified Bodies & Certificates module. This requires that the manufacturer have completed their Actor registration.
Further, all custom-made device manufacturers will be required to submit vigilance and post-market surveillance data into EUDAMED. Therefore, if they have to submit a serious incident or trend report, they will need to register in the Actor module, in order to have access to the vigilance module.
Manufacturers of custom-made devices are not issued a Single Registration Number. Instead, they are issued an Actor ID. For all practical purposes, the Actor ID and SRN look the same and serve the same purpose.